David Stackhouse Email & Phone Number

Chapel Hill, NC, US

New York, New York, US

New York, New York, US

New York, New York, US

• Currently acts as the project manager and lead engineer for a $2M CapEx acquisition of a new UFDF system. Responsibilities include managing the automation, single-use, and design workstreams, as well as designing user.
• Manages projects including commercial change controls, CAPAs, audit observations, capital, and continuous improvement
• Establishes and owns process control strategy for upstream and downstream production
• Designs technical and engineering studies, writing technical summary reports and generating data to support impact assessments, process transfers, and investigations
• Authors and designs equipment MBRs and SOPs, user requirements, and risk assessments
• Provides direct production support during processing operations to maintain plan of record

Melbourne, Victoria, AU

• Acted as the downstream SME for the Viral Pilot Plant, designing, optimizing, and running unit processes and procedures for UF/DF, chromatography, centrifugation, resin adsorption, and hydrolysis
• Troubleshot and investigated process related issues, coordinating with appropriate teams to resolve issues and prevent reoccurrence
• Generated equipment design specifications and liaised with related vendors
• Provided technical information, training, and coaching for process-related matters within production to maximize process understanding and enhance knowledge-based decision making.
• Executed process validations and short-term improvement projects, liaising with all the relevant parties to ensure accurate execution
• Contributed to Annual Product Reviews and Product Quality Reviews for analysis and process technology innovations.

Melbourne, Victoria, AU

• Worked on a project with manufacturing and QC to save wasted materials
• Executed process steps according to defined SOPs and BPRs
• Documented activities in accordance with cGMPs
• Edited and revised SOPs
• Interfaced with process automation systems and electronic business systems (DeltaV, OEM, LIMS, SAP, PI)

New York, New York, US

• Worked on a project to create a vessel mixing database and platform document, which is used by technical operations and QA to save time, money, and resources, as well as be an asset utilized during validation and audits
• Created job aids for effective utilization of the vessel mixing database and platform
• Worked in a cGMP facility and utilized cGMP good documentation practices
• Assisted in assembling technical documents for use in a biologics license application
• Assisted other interns in designing, presenting, and establishing an onsite mentorship program to promote the knowledge transfer of core company values and skills

• Worked on a project to develop study protocols and analytical methods, which were then used to perform surface challenge tests on sporicidal disinfectants commonly found in biomanufacturing
• Developed analytical methods for enumerating bacterial spores from biologicalindicators and surfaces
• Created study protocols and SOPs accommodating state of the art sterilizing agents such as AIHP, SporGon, and SporKlenz
• Performed surface challenge tests on accelerated ionized hydrogen peroxide, SporGon,and SporKlenz utilizing the methods and the protocols previously developed
• Presented the SOPs, research, and results of the project at the NC State Summer Undergraduate Research Symposium

Bachelor'S Degree, Chemical Engineering, Biomanufacturing Minor

Undergraduate Transfer Courses

Undergraduate Transfer Courses